Viewing data from:

ONYDA XR

NDA

CLONIDINE HYDROCHLORIDE | N217645 | TRIS PHARMA INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

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Today

8062667

Mar. 29, 2029

11918689

Jul. 28, 2041

12576032

Jul. 28, 2041

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

174 trials from ClinicalTrials.gov — 1 recruiting, 3 active, 114 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia NCT03121261	Phase 4	Active	University Hospital Dubrava	60	2017-05-01 → 2028-10
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy NCT03092011	Phase 4	Active	The Cooper Health System	69	2018-02-21 → 2026-12-01
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients NCT01530373	Phase 2	Recruiting	University of Arkansas	110	2012-02 → 2028-09
A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease NCT01370811	Phase 2	Completed	Orient Pharma Co., Ltd.	24	2011-08 → 2012-09
Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery NCT01597427	Phase 2	Completed	Federal University of São Paulo	29	2009-03 → 2012-03
The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine NCT01620112	Phase 2	Completed	Universidade Federal do Rio de Janeiro	60	2009-02 → 2011-07
Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure NCT01761916	Phase 4	Completed	Instituto Materno Infantil Prof. Fernando Figueira	90	2013-01 → 2013-06
Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty?NCT02276495	N/A	Completed	University of California, Irvine	55	2015-01-01 → 2024-09-30
Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?NCT02361476	Phase 4	Completed	Rigshospitalet, Denmark	379	2015-01 → 2015-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$13.38

per ml

Lowest NADAC/Unit

$13.38

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24478014803ONYDA XR 0.1 MG/ML SUSPENSION	$13.38	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$306.23

Highest Price

$400.97

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24478-0148-03ONYDA XR 0.1ML/ML SUSP,SA	$400.97	FSS	Tris Pharma, Inc.	08/31/2028
24478-0148-03ONYDA XR 0.1ML/ML SUSP,SA	$306.23	Big4	Tris Pharma, Inc.	08/31/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs6 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

PCASCLONIDINE HYDROCHLORIDE

DMF 47781983

UNICHEM LABORATORIES LTDCLONIDINE HYDROCHLORIDE USP

DMF 169292003

ALEMBIC PHARMACEUTICALS LTDCLONIDINE HYDROCHLORIDE USP

DMF 223622008

YUNG ZIP CHEMICAL IND CO LTDCLONIDINE HYDROCHLORIDE

DMF 239062010

ENALTEC LABS PRIVATE LTDCLONIDINE HYDROCHLORIDE USP

DMF 313862017

LUSOCHIMICA SPAInactiveCLONIDINE HYDROCHLORIDE

DMF 59981985

ORCHIMIE SAInactiveCLONIDINE HYDROCHLORIDE

DMF 60141985

YUNG ZIP CHEMICAL INDUSTRY COMPANY LTDInactiveCLONIDINE HYDROCHLORIDE

DMF 61281985

DAIWA PHARMACEUTICAL CO LTDInactiveCLONIDINE HYDROCHLORIDE

DMF 63071986

UNICHEM LABORATORIES LTDInactiveCLONIDINE HYDROCHLORIDE

DMF 63571986

KV PHARMACEUTICAL COInactiveCLONIDINE HYDROCHLORIDE CONTROLLED RELEASE CAPSULES 0.2 MG.

DMF 76311988

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 14, 2025	SUPPL -4	View Letter (PDF)
Dec 9, 2024	SUPPL -1	View Letter (PDF)
May 28, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1MG/ML

RLD

3 patents0 exclusivities▴

SUSPENSION, EXTENDED RELEASE;ORAL | Approved: May 24, 2024

Patents (3) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8062667	Mar 29, 2029	—	—	Yes	—	—
11918689	Jul 28, 2041	—	—	Yes		—
12576032	Jul 28, 2041	—	—	—		—